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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PROGRAMMING SOFTWARE

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CYBERONICS INC PROGRAMMING SOFTWARE Back to Search Results
Model Number 250
Event Date 06/10/2009
Event Type  Malfunction  
Event Description

It was reported to manufacturer that when the nurse was reviewing the magnet activation history on the hand held display, that the magnet activations had a lot of times on one row, and that did not appear to be correct. Further review of the generator programming history that was downloaded from the sites hand held and returned to manufacturer revealed that the generator total operating time had rolled over. Further manufacturer investigation has determined that the root cause for the magnet activations being displayed as multiple dates/times per row is due to the local array (b) (4) being mis-declared as static variable, however, the trigger for this event has been identified to be the result of the generator's total operating time rolling over. The event will be corrected once 15 magnet activations have registered following the total operating time rollover.

 
Manufacturer Narrative

Analysis of programming history performed.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1472790
Report Number1644487-2009-01466
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/11/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/09/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number250
Device LOT Number521382
OTHER Device ID NumberVERSION 7.1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/11/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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